Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263101
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-01-30
Brief Title:
Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Laparoscopic Colorectal Surgery
Sponsor:
Chaoyang Hospital of China Medical University
Organization:
Chaoyang Hospital of China Medical University
Study Overview
Official Title:
Drainage Fluid Biomarkers and Postoperative Gastrointestinal Dysfunction in Colorectal Surgery A Monocentric Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postoperative gastrointestinal dysfunction POGD often referred to as postoperative ileus POI after colorectal surgery is characterized by symptoms such as nausea vomiting abdominal distension and delayed bowel movements The incidence of this issue varies among medical institutions impacting patient nutrition prolonging hospital stays and increasing healthcare costs
The complex pathogenesis of POGD involves a brief neurogenic phase within 3 hours and a more prolonged inflammatory phase beginning at 3-4 hours and lasting for days The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer Subsequently it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells which contributes to the development and exacerbation of POGD Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function
This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery ERAS
The complex pathogenesis of POGD involves a brief neurogenic phase within 3 hours and a more prolonged inflammatory phase beginning at 3-4 hours and lasting for days The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer Subsequently it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells which contributes to the development and exacerbation of POGD Studies have demonstrated changes in inflammatory cells and factors in the abdominal fluid following abdominal surgery emphasizing the clinical significance of analyzing drainage fluid to predict postoperative gastrointestinal function
This study analyzes inflammatory markers in drainage fluid following laparoscopic colorectal cancer surgery The aim is to enhance the accuracy of predicting gastrointestinal recovery outcomes and contribute to the evolving field of Enhanced Recovery After Surgery ERAS
Detailed Description:
Postoperative gastrointestinal dysfunction POGD often referred to as postoperative ileus POI is a common gastrointestinal issue that frequently occurs after colorectal surgery It is characterized by symptoms such as nausea and vomiting abdominal distension and delayed defecation and evacuation The incidence of POI is not clearly defined due to the varying definitions across healthcare institutions but it is estimated to be approximately 10-30 and is one of the most common complications after colorectal surgery The occurrence of POI increases the nutritional risk of patients eg malnutrition myasthenia gravis malignant morbidity prolongs the length of hospital stay increases hospital costs and significantly adds to the health economic burden
In 2018 the American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement considered abandoning the traditional definition of POI and proposed a scoring system based on intake sensation of nausea vomiting physical examination and duration of symptoms I-FEED They also introduced a definition of postoperative gastrointestinal dysfunction POGD based on scores classifying postoperative gastrointestinal function as normal 0-2 postoperative gastrointestinal intolerance POGI 3-5 and postoperative gastrointestinal dysfunction POGD 6
The complex pathogenesis of POGD involves a brief neurogenic phase within 3 hours and a more prolonged inflammatory phase beginning at 3-4 hours and lasting for days The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer Subsequently it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells which contributes to the development and exacerbation of POGD
Levels of inflammatory cells and factors in the peritoneal fluid are changed following abdominal surgery in both rodents and humans Many previous studies have confirmed that the use of drainage fluids also reduces the incidence of elevated inflammatory markers such as CRP in the presence of unrelated inflammatory stimuli such as concurrent infections and systemic diseases For instance in other diseases like meningitis blood IL-6 is less specific than IL-6 in the drainage fluid In addition abdominal drainage fluid is more effective and efficient than routinely collected blood for detecting anastomotic leakage AL following colorectal cancer surgery However fewer studies have been conducted to predict the recovery of postoperative gastrointestinal function by analyzing drainage fluid We believe that analyzing postoperative gastrointestinal drainage fluid is of greater clinical importance in predicting postoperative gastrointestinal function
In our study we collected abdominal drainage fluid near the anastomosis on the first and third day after laparoscopic colorectal cancer surgery for biochemical and cytological tests These tests included lactate dehydrogenase LDH adenosine deaminase ADA and albumin We also performed conventional cytological tests for neutrophils lymphocytes monocytes etc In addition we calculated inflammatory indices such as neutrophil-lymphocyte ratio NLR lymphocyte-monocyte ratio LMR and prognostic nutrition index PNI We also collected peripheral blood for the same cytological indices and evaluated the outcome of the patients gastrointestinal function recovery using the I-FEED score In addition we analyzed the correlation between the above indices and PODG and combined the inflammation indices of peritoneal drainage and serum to predict the outcome of gastrointestinal function recovery after laparoscopic colorectal cancer surgery aiming to improve the accuracy and effectiveness of prediction and accelerate patient recovery
In 2018 the American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement considered abandoning the traditional definition of POI and proposed a scoring system based on intake sensation of nausea vomiting physical examination and duration of symptoms I-FEED They also introduced a definition of postoperative gastrointestinal dysfunction POGD based on scores classifying postoperative gastrointestinal function as normal 0-2 postoperative gastrointestinal intolerance POGI 3-5 and postoperative gastrointestinal dysfunction POGD 6
The complex pathogenesis of POGD involves a brief neurogenic phase within 3 hours and a more prolonged inflammatory phase beginning at 3-4 hours and lasting for days The inflammatory phase is crucial and is recognized as initiated by mast cells and damage-associated molecular patterns that activate macrophages in the intestinal muscle layer Subsequently it triggers a series of cascading inflammation reactions through the release of inflammatory factors and recruitment of inflammatory cells which contributes to the development and exacerbation of POGD
Levels of inflammatory cells and factors in the peritoneal fluid are changed following abdominal surgery in both rodents and humans Many previous studies have confirmed that the use of drainage fluids also reduces the incidence of elevated inflammatory markers such as CRP in the presence of unrelated inflammatory stimuli such as concurrent infections and systemic diseases For instance in other diseases like meningitis blood IL-6 is less specific than IL-6 in the drainage fluid In addition abdominal drainage fluid is more effective and efficient than routinely collected blood for detecting anastomotic leakage AL following colorectal cancer surgery However fewer studies have been conducted to predict the recovery of postoperative gastrointestinal function by analyzing drainage fluid We believe that analyzing postoperative gastrointestinal drainage fluid is of greater clinical importance in predicting postoperative gastrointestinal function
In our study we collected abdominal drainage fluid near the anastomosis on the first and third day after laparoscopic colorectal cancer surgery for biochemical and cytological tests These tests included lactate dehydrogenase LDH adenosine deaminase ADA and albumin We also performed conventional cytological tests for neutrophils lymphocytes monocytes etc In addition we calculated inflammatory indices such as neutrophil-lymphocyte ratio NLR lymphocyte-monocyte ratio LMR and prognostic nutrition index PNI We also collected peripheral blood for the same cytological indices and evaluated the outcome of the patients gastrointestinal function recovery using the I-FEED score In addition we analyzed the correlation between the above indices and PODG and combined the inflammation indices of peritoneal drainage and serum to predict the outcome of gastrointestinal function recovery after laparoscopic colorectal cancer surgery aiming to improve the accuracy and effectiveness of prediction and accelerate patient recovery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None